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Brand drugmaker Advancis Pharmaceutical and generic firm Par Pharmaceutical yesterday finalized an agreement to develop and co-promote a new branded version of the widely used generic antibiotic amoxicillin.
The Commerce Department is asking for comments from industry about drug-pricing practices in Organization for Economic Cooperation and Development (OECD) member countries, and the effects those practices have on drug pricing in the U.S.
Generic drugmaker Sandoz expects to launch the first generic biologic on the market — its follow-on human growth hormone product Omnitrop — next year in Europe.
The FDA has issued a final guidance on how drugmakers, laboratories and others should handle reserve testing samples for bioavailabilty (BA) and bioequivalence (BE) studies used to support new and generic drug applications.
A California drugmaker has received a warning letter from the FDA for a direct-to-consumer TV ad and website that omitted or minimized risk information and made unsubstantiated effectiveness claims for an erectile dysfunction product.
A California drugmaker and a New York dietary supplement manufacturer have been issued warning letters for a print promotion and product claims that violate the Federal Food, Drug and Cosmetic Act.